US20220218184A1 - Magnetically controlled power button and gyroscope external to the lung used to measure orientation of instrument in the lung - Google Patents
Magnetically controlled power button and gyroscope external to the lung used to measure orientation of instrument in the lung Download PDFInfo
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Abstract
A luminal navigation system including a catheter including a sensor and a pod including a wireless communication device, the wireless communication device transmitting data received from the sensor.
Description
- This application claims the benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 63/137,483, filed on Jan. 14, 2021, the entire content of which is hereby incorporated by reference herein.
- This disclosure relates to surgical systems, and more particularly, to systems for intraluminal navigation such as navigation within the lungs.
- There are several commonly applied medical methods, such as endoscopic procedures or minimally invasive procedures, for treating various maladies affecting organs including the liver, brain, heart, lungs, gall bladder, kidneys, and bones. Often, one or more imaging modalities, such as magnetic resonance imaging (MRI), ultrasound imaging, computed tomography (CT), or fluoroscopy are employed by clinicians to identify and navigate to areas of interest within a patient and ultimately a target for biopsy or treatment. In some procedures, pre-operative scans may be utilized for target identification and intraoperative guidance. However, real-time imaging may be required to obtain a more accurate and current image of the target area. Furthermore, real-time image data displaying the current location of a medical device with respect to the target and its surroundings may be needed to navigate the medical device to the target in a safe and accurate manner (e.g., without causing damage to other organs or tissue).
- For example, an endoscopic approach has proven useful in navigating to areas of interest within a patient, and particularly so for areas within luminal networks of the body such as the lungs. To enable the endoscopic approach, and more particularly the bronchoscopic approach in the lungs, endobronchial navigation systems have been developed that use previously acquired Mill data or CT image data to generate a three-dimensional (3D) rendering, model, or volume of the particular body part such as the lungs.
- The resulting volume generated from the MM scan or CT scan is then utilized to create a navigation plan to facilitate the advancement of a navigation catheter (or other suitable medical device) through a bronchoscope and a branch of the bronchus of a patient to an area of interest. A locating or tracking system, such as an electromagnetic (EM) tracking system, may be utilized in conjunction with, for example, CT data, to facilitate guidance of the navigation catheter through the branch of the bronchus to the area of interest. In certain instances, the navigation catheter may be positioned within one of the airways of the branched luminal networks adjacent to, or within, the area of interest to provide access for one or more medical instruments.
- Despite the successes of these systems, improvements are always desired to promote the efficient use of these systems and overcome challenges in use of these systems.
- One aspect of the disclosure is directed to a luminal navigation system including: a catheter configured for insertion into a bronchoscope, the catheter including a five degree of freedom (5DOF) sensor at a distal portion of the catheter. The luminal navigation system also includes a locating module configured to receive signals from the 5DOF sensor to determine an X, Y, Z location and pitch and yaw orientation of the distal portion of the catheter. The luminal navigation system also includes a pod, configured to be received between a telescoping portion of the catheter and a hub of the catheter, the pod including a wireless communication device. The luminal navigation system also includes a gyroscopic sensor located in the pod, where the gyroscopic sensor determines an amount of roll experienced by the pod, where the pod is configured to receive signals from the 5DOF sensor and the gyroscopic sensor and to transmit to the locating module the received signals and the locating module can determine the position and orientation of the distal portion of the catheter in six degrees of freedom (6DOF). Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
- Implementations of this aspect of the disclosure may include one or more of the following features. The luminal navigation system further including a locatable guide configured for insertion into a lumen of the catheter, the locatable guide including a 6DOF sensor at a distal end and a handle on a proximal end, where signals generated by the 6DOF sensor are transmitted to the locating module. The luminal navigation system where the 6DOF sensor and the 5DOF sensor are electromagnetic sensors configured to detected magnetic fields generated by a magnetic field generator. The luminal navigation system where the pod includes an EM field detector, wherein the pod fully powers on upon detection of a magnetic field. The luminal navigation system where the pod further includes a rechargeable battery. The luminal navigation system further including a charger configured to receive the pod and to charge the rechargeable battery. The luminal navigation system where the charger is configured for wireless charging of the rechargeable battery in the pod.
- Another aspect of the disclosure is directed to a luminal navigation system including: a catheter configured for insertion into a bronchoscope, the catheter including a five degree of freedom (DOF) sensor at a distal portion of the catheter. The luminal navigation system also includes a locating module configured to receive signals from the 5DOF sensor to determine an X, Y, Z location and pitch and yaw orientation of the distal portion of the catheter. The luminal navigation system also includes a locatable guide configured for insertion into a lumen of the catheter, the locatable guide including a 6DOF sensor at a distal end and a handle on a proximal end, where signals generated by the 6DOF sensor are transmitted to the locating module. The luminal navigation system also includes a pod, configured to be received between a telescoping portion of the catheter and a hub of the catheter, the pod including a wireless communication device; where the locating module receives the output from the 6DOF sensor via a cable while the locatable guide is secured in the catheter and from the 5DOF sensor via the wireless communication device following removal of the locatable guide from the catheter. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
- Implementations of this aspect of the disclosure may include one or more of the following features. The luminal navigation system further including a gyroscopic sensor located in the pod, where the gyroscopic sensor determines an amount of roll experienced by the pod. The luminal navigation system where the pod is configured to receive signals from the 5DOF sensor and the gyroscopic sensor and to transmit to the locating module the received signals and the locating module can determine the position and orientation of the distal portion of the catheter in six degrees of freedom (6DOF). The luminal navigation system wherein the pod includes an EM field detector, wherein the pod fully powers on upon detection of a magnetic field. The luminal navigation system where the 6DOF sensor and the 5DOF sensor are electromagnetic sensors configured to detected magnetic fields generated by a magnetic field generator. The luminal navigation system where the pod further includes a rechargeable battery. The luminal navigation system further including a charger configured to receive the pod and to charge the rechargeable battery. The luminal navigation system where the charger is configured for wireless charging of the rechargeable battery in the pod. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
- A further aspect of the disclosure is directed to a wireless transmitter pod for a luminal navigation catheter, including: a housing configured to mate with a catheter, the catheter including a five degrees of freedom (5DOF) sensor formed on a distal end. The wireless transmitter pod also includes a rechargeable battery secured within the housing. The wireless transmitter pod also includes a wireless communication device secured within the housing. The wireless transmitter pod also includes a gyroscopic sensor secured within the housing. The wireless transmitter pod also includes a microcontroller configured to receive signals from the 5DOF sensor and the gyroscopic sensor and to output via the wireless communication device a signal from which a position and orientation of distal portion of the catheter in six degrees of freedom (6DOF). Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
- Implementations of this aspect of the disclosure may include one or more of the following features. The wireless transmitter pod further including at least one light-emitting diode configured to indicate a status of the rechargeable battery. The wireless transmitter pod further including at least one light emitting diode configured to indicate a connection status of the wireless communication device. The wireless transmitter pod further configured to receive a hub of the catheter, where the hub enables electrical connectivity of the sensor to the microcontroller. The wireless transmitter pod where the sensor is an electromagnetic sensor. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
- Various aspects and features of the disclosure are described hereinbelow with references to the drawings, wherein:
-
FIG. 1 is a schematic illustration of a system in accordance with the disclosure; -
FIG. 2A is a profile view of a catheter in accordance with the disclosure; -
FIG. 2B is a detailed view of a portion ofFIG. 2A showing the insertion of a cable; -
FIG. 3A is a profile view of a locatable guide in accordance with the disclosure; -
FIG. 3B is a profile view of the locatable guide ofFIG. 3A inserted into the catheter ofFIG. 2A ; -
FIG. 3C is a profile view of a portion ofFIG. 3A showing the insertion of a cable; -
FIG. 4 is a perspective view of a wireless transmission pod incorporated as part of the catheter ofFIG. 2A ; -
FIG. 5 is a perspective view of a wireless transmission pod; -
FIG. 6A is a top perspective view of a charger in accordance with the disclosure; -
FIG. 6B is a side perspective view of the charger ofFIG. 6A in accordance with the disclosure; -
FIG. 7A is an end view of the wireless transmission pod ofFIG. 5 ; -
FIG. 7B is a cross-sectional view of the wireless transmission pod ofFIG. 5 ; -
FIG. 8A is a comparative view of the wireless transmission pod incorporated as part of a catheter ofFIG. 4 and the wireless transmission pod ofFIG. 5 ; -
FIG. 8B depicts the wireless transmission pod incorporated as part of a catheter being held by a user; -
FIGS. 9A-9E depict an alternative form of a wireless transmission pod and its incorporation into a catheter in accordance with the disclosure; -
FIGS. 10A-10C depict a charger for use with the wireless transmission pods ofFIG. 9A ; -
FIGS. 11A-11E depict an alternative form of a wireless transmission pod and its incorporation into a catheter in accordance with the disclosure; -
FIGS. 12A-12D depict a charger for use with the wireless transmission pods ofFIG. 11A ; -
FIGS. 13A and 13B depict an alternative form of a wireless transmission pod and its incorporation into a catheter in accordance with the disclosure; -
FIGS. 14A-14E depict an alternative form of a wireless transmission pod and its incorporation into a catheter in accordance with the disclosure; and -
FIGS. 15A-15D depict a charger for use with the wireless transmission pods ofFIG. 14A . - This disclosure is directed to improvements to electromagnetic (EM) navigation systems such as the ILLUMISITE system sold by MEDTRONIC PLC. In one aspect the disclosure is directed to a system enabling wireless (e.g., BLUETOOTH, or others) communication between a catheter or extended working channel (EWC) and navigation software components of the EM navigation system. Such wireless communication helps eliminate wire entanglement issues that can present themselves in currently available systems. A further aspect of the disclosure is directed to a system and method that can determine in six degrees of freedom (6DOF), X, Y, Z, pitch, yaw, and roll, the position and orientation of the distal end of the catheter or EWC within the patient. In particular, the disclosure is directed to determining the amount of roll experienced at the distal end of the catheter utilizing a gyroscopic sensor located on a proximal end of the catheter. This data can be combined with a 5DOF EM sensor located on the distal end of the catheter to provide accurate position and orientation data of the distal portion of the catheter.
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FIG. 1 is a perspective view of anexemplary system 100 in accordance with the disclosure.System 100 includes a table 102 on which a patient P is placed. Abronchoscope 104 is inserted into an opening in the patient. The opening could be a natural opening such as the mouth, nose, or anus. Alternatively, the opening may be formed in the patient, for example a surgical port or a simple incision. Thebronchoscope 104 may include one or more optical sensors for capturing live images and video as thebronchoscope 104 is navigated into the patient P. Acatheter 106 may be inserted into thebronchoscope 104 for navigating to portions of the anatomy into which thebronchoscope 104 cannot pass. A variety of tools (not shown) such as a biopsy needle, ablation needle, clamp, forceps, or others may be inserted into thecatheter 106 to achieve a desired therapeutic or diagnostic purpose. One ormore sensors 107 may be located at a distal end of thecatheter 106. Amonitor 108 may be employed to display images captured by the optical sensor on thebronchoscope 104 as it is navigated within the patient P. - The
system 100 includes alocating module 110 which receives signals fromcatheter 106 andsensors 107 and processes the signals to generate useable data, as described in greater detail below. Acomputer 112, including adisplay 114 receives the useable data from the locatingmodule 110, and incorporates the data into one or more applications running on thecomputer 112 to generate one or more user-interfaces that are presented on thedisplay 114. Both thelocating module 110 and themonitor 108 may be incorporated into or replaced by applications running on thecomputer 112 and images presented via a user interface on thedisplay 114. Also depicted inFIG. 1 is afluoroscope 116 which may be employed to construct fluoroscopic based three-dimensional volumetric data of a target area from 2D fluoroscopic images and other imaging techniques. As will be appreciated thecomputer 112 incudes a computer readable recording medium such as a memory for storing image data and applications that can be executed by a processor in accordance with the disclosure to perform some or all of the steps of the methods described herein. - There are known in the art a variety of pathway planning applications for pre-operatively planning a path through a luminal network such as the lungs or the vascular system. Typically, a pre-operative image data set such as one acquired from a CT scan or an MM scan is presented to a user. The target identification may be automatic, semi-automatic, or manual, and allows for determining a pathway through patient P's airways to tissue located at and around the target. In one variation the user scrolls through the image data set, which is presented as a series of slices of the 3D image data set output from the CT scan. By scrolling through the images, the user manually identifies targets within the image data set. The slices of the 3D image data set are often presented along the three axes of the patient (e.g., axial, sagittal, and coronal) allowing for simultaneous viewing of the same portion of the 3D image data set in three separate 2D images.
- Additionally, the 3D image data set (e.g., acquired from the CT scan) may be processed and assembled into a three-dimensional CT volume, which is then utilized to generate a 3D model of patient P's airways by various segmentation and other image processing techniques. Both the 2D slices images and the 3D model may be displayed on a
display 114 associated withcomputer 112. Usingcomputer 112, various views of the 3D or enhanced 2D images may be generated and presented. The enhanced two-dimensional images may possess some three-dimensional capabilities because they are generated from the 3D image data set. The 3D model may be presented to the user from an external perspective view, an internal “fly-through” view, or other views. After identification of a target, the application may automatically generate a pathway to the target. In the example of lung navigation, the pathway may extend from the target to the trachea, for example. The application may either automatically identify the nearest airway to the target and generate the pathway, or the application may request the user identify the nearest or desired proximal airway in which to start the pathway generation to the trachea. Once selected, the pathway plan, three-dimensional model, and 3D image data set and any images derived therefrom, can be saved into memory on thecomputer 112 and made available for use during a procedure, which may occur immediately following the planning or at a later date. - Following, the planning phase, where targets are identified and pathways to those targets are created, a navigation phase can be commenced. With respect to the navigation phase, the locating
module 110 is employed to detect the position and orientation of a distal portion of thecatheter 106. The locatingmodule 110 may utilize atransmitter mat 118 to generate an electromagnetic field in which the position ofsensors 107 are placed. Thesensors 107 generate a current when placed in the electromagnetic field is received by the locatingmodule 110 and either five or six degrees of freedom (DOF) of the position of thesensor 107 andcatheter 106 is determined. To accurately reflect the detected position of thecatheter 106 in the pre-procedure image data set (e.g., CT or MRI images) or 3D models generated therefrom, a registration process must be undertaken. - Registration of the patient P's location on the
transmitter mat 118 may be performed by movingsensor 107 through the airways of the patient P. More specifically, data pertaining to locations ofsensor 107, whilecatheter 106 is moving through the airways, is recorded usingtransmitter mat 118 and locatingmodule 110. A shape resulting from this location data is compared to an interior geometry of passages of the three-dimensional model generated in the planning phase, and a location correlation between the shape and the three-dimensional model based on the comparison is determined, e.g., utilizing the software oncomputer 112. In addition, the software identifies non-tissue space (e.g., air filled cavities) in the three-dimensional model. The software aligns, or registers, an image representing a location ofsensor 107 with the three-dimensional model and/or two-dimensional images generated from the three-dimension model, which are based on the recorded location data and an assumption thatsensor 104locatable guide 110 remains located in non-tissue space in patient P's airways. - Though described herein with respect to EMN systems using
EM sensor sensors 107 are not so limited, and the sensors may be one or more of an inertial measurement unit, shape sensor, optical sensor, ultrasound sensor, and others. Additionally, the methods described herein may be used in conjunction with robotic systems such that robotic actuators (not shown) drive thecatheter 106 proximate the target. -
FIG. 2A depicts a detailed view of thecatheter 106, withsensor 107 located at the distal end. On a proximal end of thecatheter 106, ahub 202 connects to the atelescopic portion 204 having atelescope hub 206 for connection to a bronchoscope adapter (not shown) such that thecatheter 106 can be inserted into the working channel of abronchoscope 104. Thehub 202 is electrically connected to thesensor 107. As shown inFIG. 2B , acable 208 is inserted into thehub 202 to connect thehub 202 and therewith thesensor 107 to thelocating module 110 and thecomputer 112 via a wired connection. As described, above, the data output by thesensor 107 is used to determine the position and orientation of thecatheter 106 in the patient. -
FIG. 3A depicts alocatable guide 300. Thelocatable guide 300 is a sensor catheter that includes asensor 107 at the distal end of acatheter 302 and ahandle 304 at the proximal end. Thelocatable guide 300 is configured for insertion into thecatheter 106, as depicted inFIG. 3B . Thehandle 304 is in electrical communication with thesensor 107.FIG. 3C depicts the insertion of acable 306 into thehandle 304 to therewith electrically connect thesensor 107 with the locatingmodule 110 and thecomputer 112 via a wired connection. - In practice, while navigating the
catheter 106 to a target in the lung, following the navigation pathway, the data from thesensor 107 in thelocatable guide 300 is employed for detecting location and orientation of thelocatable guide 300, and therewith the distal portion of thecatheter 106. Thesensor 107 in thelocatable guide 300 is a 6DOF sensor and provides X, Y, Z coordinates as well as pitch, yaw, and roll orientations of thesensor 107 and therewith the position and orientation of thelocatable guide 300 within the EM field generated by thetransmitter mat 118. - Upon reaching a desired position opposite a target, the
locatable guide 300 is removed from thecatheter 106 so that the lumen in the catheter is freed for insertion of other tools such as biopsy or therapeutic tools such as microwave ablation catheters, and others. With removal of thelocatable guide 300 sensor data from thesensor 107 in thecatheter 106 is now employed to detect the position of thecatheter 106. It will be appreciated that with the removal of thelocatable guide 300 and insertion of other tools the position of the distal portion of thecatheter 106 may move and its position must be updated in thedisplay 114 of the navigation view to accurately show the position of thecatheter 106 in the 3D models and therewith in the patient. However, thesensor 107 in thecatheter 106 is a 5DOF sensor and outputs only X, Y, Z, coordinates and pitch and yaw orientation data. Utilizing current EM sensor technology, and because of the need to maintain the lumen opening through thecatheter 106, thesensor 107 in thecatheter 106 does not provide an output that can be used to determine the roll orientation of the distal portion of thecatheter 106. - Though described above as using the
sensor 107 in theLG 300 to perform the navigation of thecatheter 106 to the target following the pathway plan, the disclosure is not so limited. In some embodiments thesensor 107 in thecatheter 106 may be employed for this navigation. - Another challenge of this arrangement is the use of
cables catheter 106 through the luminal network of a patient requires repeated steps of rotation and advancement. Withcable 306 extending from thehandle 304 andcable 208 extending fromhub 202, but both leading to thelocating system 110 or tocomputer 112, the cables are likely to become intertwined and entangled with one another. This entanglement results in challenges when thelocatable guide 300 must be removed from thecatheter 106. - To alleviate the entangling issue, one aspect of the disclosure is directed to a
wireless communication pod 400 as depicted inFIG. 4 . Thepod 400 is configured to mount between thehub 202 of thecatheter 106, and the telescopic portion. Thepod 400 may be formed of a translucent material and include one or more light emitting diodes 402 (LED). The LEDs can provide indicators that thepod 400 is properly mated to thehub 202 and capable of receiving signals from thesensor 107 at the distal end of thecatheter 106 when placed in an EM field. Arechargeable battery 404 is housed within thepod 400. Those of skill in the art will recognize that a non-rechargeable battery may also be employed without departing from the scope of the disclosure. Therechargeable battery 404 is electrically connected to one or more circuit boards (not shown). The circuit boards include a BLUETOOTH transmitter or transmitter-receiver 406 capable of bidirectional or unidirectional communication with the locatingmodule 110 andcomputer 112. One ormore microcontrollers 407 may be employed to provide logical functions for thetransmitter 406, or to translate the signals derived from thesensor 107 to configure them for transmission via thetransmitter 406. Thepod 400 may further include a display 408 (e.g., a liquid crystal display or an LED indicator) indicating the battery level and other information such as connection to thesensor 107, and to thecomputer 112. Thepod 400 is intended to be re-useable, however, disposable versions are also possible. - In one aspect of the disclosure, as depicted in
FIGS. 6A and 6B thepods 400 are supplied as a pair ofpods 400 and include acharger 410 configured to receive the twopods 400. The charger includes twocavities 412 configured to receive apod 400. The cavity includes an interface for electrically connecting thecharger 410 to thepod 400 to charge thebattery 404. Thecharger 410 may also include a data connection, not shown, to enable updates of the firmware and software operating on rechargeable battery or themicrocontroller 407 or other components of thepod 400. Thecharger 410 may optionally include one ormore LEDs 418 to provide an indication of the power level ofbatteries 404 of thepods 400 while they are in thecharger 410. The charger may optionally also include adisplay 420 for displaying information regarding the status of thebatteries 404, state of charge, number of recharges before replacement of thepod 400, and other useful information to the user. Either thedisplay 420 or the LEDs (or both) may initiate when thepod 400 is placed in thecharger 410. Colored LEDS may indicate battery status. - The
charger 410 may be placed in the operating room proximate thesystem 100 such that should a battery of apod 400 run low of power during a procedure, thepod 400 may be replaced. Thecharger 410 may be a wireless charger (e.g., inductive charging) requiring no direct electrical connection between thecharger 410 and thebattery 404 in thepod 400. In addition to thesecond pod 400, which can be charging during the procedure where thefirst pod 400 is being used, the connection of thecable 208 remain available for connection to thehub 202. Accordingly, a clinician can have confidence that they will never be without a means of receiving the data from thesensor 107 on thecatheter 106. - The
pod 400 is configured to rest comfortably in the hand of the user. In accordance with this aspect, thebattery 404 is located on one side of thepod 400 and the opposite side of thepod 400 houses the circuit boards and other aspects related to the BLUETOOTH transmitter ortransmitter receiver 406. This arrangement allows the weight of the battery to be counterbalanced by the weight of thetransmitter 406 and other electrical components. Thepod 400 may automatically power up when removed from thecharger 410, lighting one of theLEDs 402, andfurther LEDs 402 may light when electrically connected to thesensor 107, and to thecomputer 112 via theBLUETOOTH transmitter 406. Aspeaker 416 may also be employed to provide audible reminders, for example to remove thepod 400 following a procedure or in combination with the connections described above and the lighting of the LEDs. - Alternatively, the
pod 400 may include anEM field detector 417. TheEM field detector 417 can detect whenever it is placed in an EM field, such as that generated by thetransmitter mat 118. Thus rather than requiring an external on/off switch to turn thepod 400 on or off, whenever thepod 400 is within the EM field, thepod 400 fully powers on. In one embodiment thepod 400 may be powered by the magnetic field. Alternatively, theEM field detector 417 can energize a switch not shown, connecting thebattery 404 to thewireless transmitter 406. In either configuration the user can be assured thatpod 400 is on and transmitting to thelocating module 110 and thecomputer 112 throughout the procedure so long as thepod 400 is in the EM field. - In a further embodiment, the
sensors 107 may effectively be the EM field detector. In such an embodiment, thesensor 107 is in communication with thePOD 400, and particularly themicrocontroller 407. When thesensor 107 is in the EM field, a current and a voltage are generated and used to determine the location of thesensor 107 in the EM field. The voltage may additionally be applied to themicrocontroller 407, and logic stored in or applied by themicrocontroller 407 upon receipt of this voltage signal can trigger thebattery 404 to fully power thepod 400. Additionally or alternatively, the current induced in thesensor 107 may be applied to thebattery 404 to charge thebattery 404 while it is in the EM field. - This arrangement allows for continued use of the
locatable guide 300 during initial navigation to a target. Further the entanglement issues stemming from having twocables wireless transmitter 406 ensures that position and orientation in 5DOF continues to be provided to thelocating module 110 andcomputer 112 from thesensor 107 at the distal end of thecatheter 106. - In a further aspect of the disclosure, in addition to the
wireless transmitter 406 and thebattery 404, there is housed in the pod 400 agyroscopic sensor 414. Thegyroscopic sensor 414 is able to determine the orientation of thepod 400 with respect to roll. Thus, there is a 0 position, and based on that known 0 position as thepod 400 is rotated, a determination can be made of how far removed from the 0 position, angle of roll thepod 400 has experienced. - The
catheter 106 is typically formed of several layers of polymeric material sandwiching a braided mesh. During manufacturing, reflowing of the polymeric materials results in the formation of a substantially uniform construction. Thecatheter 106 is flexible but retains substantial resistance to torsion along its length. As a result, a roll of thepod 400 corresponds to a roll experienced at the distal end of thecatheter 106 within some factor (e.g., 5, 10, 15, 20, 25%). Thus, by knowing the amount of roll experienced at thepod 400 the direction of roll of the distal end of thecatheter 106 is known and an estimate of the magnitude of the roll can be ascertained. - The
display 408 on thepod 400 may present an indicator of the number of degrees relative to a 0 position. For example, a +10 degree indicator could indicate a 10 degree rotation in the clockwise direction, and a −10 degree indicator a 10 degree rotation in the counterclockwise direction. - As will be appreciated, algorithms may be developed to refine the estimate based on a number of factors including rigidity of the catheter to twist, the lubricity of the outer material of the catheter, the general lubricity of the airways of a patient, the number of bends the catheter has experienced to achieve its current position, the magnitude in degrees of the bends the
catheter 106 has experienced to achieve its current position, the size of the airway in which the distal end of thecatheter 106 is currently located, an observed rate of change of position of the distal end of thecatheter 106 while the pod is being rotated, and other factors. - The roll experienced by the
pod 400, and the estimate that provides for the roll experienced by the distal end of thecatheter 106, when combined with the 5 DOF data provided by the sensor at the distal end of thecatheter 106 can be combined to provide 6 DOF sensor information about thesensor 107 and the distal end of thecatheter 106 to thelocating module 110 andcomputer 112. Such an arrangement may be used with thelocatable guide 300, as described above, and simply provide greater clarity of information after removal of thelocatable guide 300 from thecatheter 106. For instance, in its simplest form, the data may be used to provide an indicator to the clinician on thedisplay 114 that thecatheter 106 has likely experienced a roll greater than a preset amount (e.g., 5 degrees). Alternatively, it may be actively relied upon to provide updated roll information to thelocating module 110 andcomputer 112 such that the position of thecatheter 106 in the 3D model displayed on thedisplay 114 is constantly updated much the same way it was when employing thelocatable guide 300. - Alternatively, the use of the
gyroscopic sensor 414 in thepod 400 may enable elimination of the use of thelocatable guide 300 from the procedure entirely. This will result in fewer times that a clinician will have to remove a very long instrument from thecatheter 106, and in general ease the workflow of the procedure. In addition, elimination of thelocatable guide 300 reduces the number of components necessary for a procedure and thus the overall cost of a procedure, while at the same time promoting efficiency and speeding up the time of the procedure. And because thepod 400 is reusable, the overall number of disposable components is also reduced. - In this aspect of the disclosure, only the
catheter 106 need be navigated along the planned pathway to a target. The lumen of thecatheter 106 may remain open throughout the navigation phase or a tool such as a biopsy or therapy tool may be present in the lumen through the navigation. The data from thesensor 107 at the end of thecatheter 106 is combined with the data from thegyroscopic sensor 414 and transmitted via thetransmitter 406 to locatingmodule 110 andcomputer 112 such that the position of thecatheter 106 within the patient can be accurately reflected in the 3D model. - Where
fluoroscope 116 is employed, the clinician may navigate thebronchoscope 104 andcatheter 106 proximate a target. Once proximate the target, a fluoroscopic sweep of images may be acquired. This sweep is a series of images (e.g., video) acquired for example from about 15-30 degrees left of the AP position to about 15-30 degrees right of the AP position. Once acquired, the clinician may be required to mark one or more of thebronchoscope 104,catheter 106, or target 308 in one or more images. Alternatively, image processing techniques may also be used to automatically identify thebronchoscope 104,catheter 106, or target 308. For example, an application running oncomputer 112 may be employed to identify pixels in the images having relevant Hounsfield units that signify the density of thebronchoscope 104 andcatheter 106. The last pixels before a transition to a less dense material may be identified as the distal locations of thebronchoscope 104 andcatheter 106. This may require a determination that the pixels having the Hounsfield unit value indicating a high-density material extent in a longitudinal direction at least some predetermined length. In some instances, the target may also be identified based on its difference in Hounsfield unit value as compared to surrounding tissue. With thebronchoscope 104 andcatheter 106 positively identified, a 3D volumetric reconstruction of the luminal network can be generated. The 3D volumetric construction may then be analyzed using similar image processing techniques to identify those pixels in the image having a Hounsfield unit signifying the density of the airway wall. Alternatively, the imaging processing may seek those pixels having a Hounsfield unit signifying air. In this process, all of the pixels having a density of air are identified until a change in density is detected. By performing this throughout the 3D volumetric construction, the relative position and orientation of the target and thecatheter 106 can be determined and used to update their depicted positions in the 3D model oncomputer 112. -
FIG. 7A depicts a top end view of thewireless transmission pod 400 andFIG. 7B depicts a cross sectional view of the wireless transmission pod.FIG. 8A depicts a comparative view of thewireless transmission pod 400 incorporating thecatheter 106 and hub 200.FIG. 8B shows thewireless transmission pod 400, hub 200, andcatheter 106 in the hand of the user as it might be used during a procedure. - While the foregoing has described specific functionality of the
wireless transmission pod 400 and its incorporation with thecatheter 106.FIGS. 9A and 9B depict an alternative form of thewireless transmission pod 400.FIGS. 9C-9E depict various views of insertion of thewireless pod 400 of inserted into the hub 200 withcatheter 106.FIGS. 10A-C depict a charger for receiving and recharging the internal battery of thewireless transmission pod 400 ofFIGS. 9A and 9B . -
FIGS. 11A and 11B depict another alternative form of thewireless transmission pod 400. The version inFIGS. 11A and 11B are similar in form to that depicted inFIG. 5 .FIGS. 11C-11E depict various views of insertion of thewireless pod 400 of inserted into the hub 200 withcatheter 106.FIGS. 12A-D depict a charger for receiving and recharging the internal battery of thewireless transmission pod 400 ofFIGS. 11A and 11B . -
FIGS. 13A and 13B depict another alternative form of thewireless transmission pod 400. As shown inFIG. 13B thewireless transmission pod 400 receives the hub 200 and also provides for a convenient handle for grasping the assembly.FIGS. 14A and 14B depict another alternative form of thewireless transmission pod 400.FIGS. 14C-14E depict various views of insertion of thewireless pod 400 of inserted into the hub 200.FIGS. 15A-D depict a charger for receiving and recharging the internal battery of thewireless transmission pod 400 ofFIGS. 14A and 14B . - Throughout this description, the term “proximal” refers to the portion of the device or component thereof that is closer to the clinician and the term “distal” refers to the portion of the device or component thereof that is farther from the clinician. Additionally, in the drawings and in the description above, terms such as front, rear, upper, lower, top, bottom, and similar directional terms are used simply for convenience of description and are not intended to limit the disclosure. In the description hereinabove, well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail.
- While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments.
Claims (20)
1. A luminal navigation system comprising:
a catheter configured for insertion into a bronchoscope, the catheter including a five degree of freedom (5DOF) sensor at a distal portion of the catheter;
a locating module configured to receive signals from the 5DOF sensor to determine an X, Y, Z location and pitch and yaw orientation of the distal portion of the catheter;
a pod, configured to be received between a telescoping portion of the catheter and a hub of the catheter, the pod including a wireless communication device; and
a gyroscopic sensor located in the pod, wherein the gyroscopic sensor determines an amount of roll experienced by the pod, wherein the pod is configured to receive signals from the 5DOF sensor and the gyroscopic sensor and to transmit to the locating module the received signals and the locating module can determine the position and orientation of the distal portion of the catheter in six degrees of freedom (6DOF).
2. The luminal navigation system of claim 1 further comprising a locatable guide configured for insertion into a lumen of the catheter, the locatable guide including a 6DOF sensor at a distal end and a handle on a proximal end, wherein signals generated by the 6DOF sensor are transmitted to the locating module.
3. The luminal navigation system of claim 2 , wherein the 6DOF sensor and the 5DOF sensor are electromagnetic sensors configured to detected magnetic fields generated by a magnetic field generator.
4. The luminal navigation system of claim 1 , wherein the pod includes an EM field detector, wherein the pod fully powers on upon detection of a magnetic field.
5. The luminal navigation system of claim 1 , wherein the pod further includes a rechargeable battery.
6. The luminal navigation system of claim 5 , further comprising a charger configured to receive the pod and to charge the rechargeable battery.
7. The luminal navigation system of claim 6 , wherein the charger is configured for wireless charging of the rechargeable battery in the pod.
8. A luminal navigation system comprising:
a catheter configured for insertion into a bronchoscope, the catheter including a five degree of freedom (DOF) sensor at a distal portion of the catheter;
a locating module configured to receive signals from the 5DOF sensor to determine an X, Y, Z location and pitch and yaw orientation of the distal portion of the catheter;
a locatable guide configured for insertion into a lumen of the catheter, the locatable guide including a 6DOF sensor at a distal end and a handle on a proximal end, wherein signals generated by the 6DOF sensor are transmitted to the locating module; and
a pod, configured to be received between a telescoping portion of the catheter and a hub of the catheter, the pod including a wireless communication device; wherein the locating module receives the output from the 6DOF sensor via a cable while the locatable guide is secured in the catheter and from the 5DOF sensor via the wireless communication device following removal of the locatable guide from the catheter.
9. The luminal navigation system of claim 8 , further comprising a gyroscopic sensor located in the pod, wherein the gyroscopic sensor determines an amount of roll experienced by the pod.
10. The luminal navigation system of claim 9 , wherein the pod is configured to receive signals from the 5DOF sensor and the gyroscopic sensor and to transmit to the locating module the received signals and the locating module can determine the position and orientation of the distal portion of the catheter in six degrees of freedom (6DOF).
11. The luminal navigation system of claim 8 , wherein the pod includes an EM field detector, wherein the pod fully powers on upon detection of a magnetic field.
12. The luminal navigation system of claim 8 , wherein the 6DOF sensor and the 5DOF sensor are electromagnetic sensors configured to detected magnetic fields generated by a magnetic field generator.
13. The luminal navigation system of claim 8 , wherein the pod further includes a rechargeable battery.
14. The luminal navigation system of claim 13 , further comprising a charger configured to receive the pod and to charge the rechargeable battery.
15. The luminal navigation system of claim 14 , wherein the charger is configured for wireless charging of the rechargeable battery in the pod.
16. A wireless transmitter pod for a luminal navigation catheter, comprising:
a housing configured to mate with a catheter, the catheter including a five degrees of freedom (5DOF) sensor formed on a distal end;
a rechargeable battery secured within the housing;
a wireless communication device secured within the housing;
a gyroscopic sensor secured within the housing,
an electromagnetic field detector configured to detect an electromagnetic field, and enable the wireless communication device to transmit when an electromagnetic field is detected;
a microcontroller configured to receive signals from the 5DOF sensor and the gyroscopic sensor and to output via the wireless communication device a signal from which a position and orientation of distal portion of the catheter in six degrees of freedom (6DOF).
17. The wireless transmitter pod of claim 16 , further comprising at least one light-emitting diode configured to indicate a status of the rechargeable battery.
18. The wireless transmitter pod of claim 16 , further comprising at least one light emitting diode configured to indicate a connection status of the wireless communication device.
19. The wireless transmitter pod of claim 16 , further configured to receive a hub of the catheter, wherein the hub enables electrical connectivity of the sensor to the microcontroller.
20. The wireless transmitter pod of claim 16 , wherein the sensor is an electromagnetic sensor.
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